Duns Number:259777209
Device Description: DROP SEAT - MAXX RAIL
Catalog Number
-
Brand Name
BARIATRIC POWER POSITIONING SYSTEM
Version/Model Number
BPPS-T
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 12, 2021
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K182995
Product Code
ITI
Product Code Name
Wheelchair, Powered
Public Device Record Key
2b54700a-06d2-4312-a9eb-89769b63840b
Public Version Date
August 13, 2021
Public Version Number
2
DI Record Publish Date
March 18, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 176 |